FDA.reportPublic FDA data

APUREE Nailtific Extra-Max Strength Daytime Antigungal

Manufacturer
Guangzhou Meixi Biotechnology Co., Ltd.
Effective date
2026-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:01

Label at a glance#

ProductAPUREE Nailtific Extra-Max Strength Daytime Antigungal
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Antibacterial and anti-itch

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid,Tolnaftate

INACTIVE INGREDIENT SECTION

PEG-8,Alcohol Denat,PEG-40 Hydrogenated Castor Oil,Menthol,Aqua,Origanum Vulgare Oil,Eugenia Caryophyllus Bud Oil,Cinnamomum Cassia Oil,Calophyllum Inophyllum Seed Oil,Melaleuca Alternifolia Leaf Oil,Eucalyptus Globulus Leaf Oil,Salicylic Acid

INDICATIONS & USAGE SECTION

15-Day & 15-Night Supply, 1.5 ml e 0.05 f. oz. each l Total 45 ml l 1.52 f. oz.

DOSAGE & ADMINISTRATION SECTION

Apply directly to the affected area

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.apuree.com/1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-423-01APUREE Nailtific Extra-Max Strength Daytime Antigungal1 in 1 BOXLIQUID11
84167-423-01APUREE Nailtific Extra-Max Strength Daytime Antigungal30 in 1 VIAL, SINGLE-USELIQUID301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84167-42384167-423-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALOPHYLLUM INOPHYLLUM SEED OILJT3LVK84A1IACT
SALICYLIC ACIDO414PZ4LPZIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
MENTHOLL7T10EIP3AIACT
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL578389D6D0IACT
AQUA059QF0KO0RIACT
SIMMONDSIA CHINENSIS SEED WAX47X6Y9FJJ2IACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PEG-8B697894SGQIACT
TOLNAFTATE06KB629TKVACTIB
UNDECYLENIC ACIDK3D86KJ24NACTIB
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
ORIGANUM VULGARE LEAF OIL7D0CGR40U1IACT
CINNAMOMUM CASSIA OILA4WO0626T5IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APUREE Nailtific Extra-Max Strength Daytime AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3d226b-57f1-75a6-e063-6394a90a96cd2026-03-30WarningsExact identifier
ndc (package): 84167-423-01
ndc (product): 84167-423
ndc11 (package): 84167042301
spl id: 4e3d226b-57f2-75a6-e063-6394a90a96cd
spl set id: 4e3d226b-57f1-75a6-e063-6394a90a96cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.